Atomoxetine, Placebo and Parent Management Training in Autism
| Status: | Completed |
|---|---|
| Conditions: | Cognitive Studies, Neurology, Psychiatric, Autism |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 5 - 14 |
| Updated: | 4/21/2016 |
| Start Date: | October 2008 |
| End Date: | April 2014 |
The study will evaluate the effectiveness of atomoxetine (Strattera) with and without Parent
Management Training (PMT) in children with Autism, Asperger's Disorder, or Pervasive
Developmental Disorder Not Otherwise Specified (PDDNOS) who have symptoms of Attention
Deficit Hyperactivity Disorder (ADHD). This is a double-blind placebo, parallel study where
the atomoxetine will have a dose titration over a 6 week period. All children will be seen
weekly during this titration period, with additional visits at Week 8 and Week 10. Families
assigned to the PMT arm will have an additional weekly meeting with a clinician for a total
of 9 PMT visits. PMT involves teaching parents to implement behavioral interventions with
their children. Subjects who are clinical responders (ADHD Responders and Compliance
Responders) from the 10 week study period will be followed every 4 weeks in a 24-week
extension study. Subjects who are clinical nonresponders will continue in PMT if they
received PMT during the double-blind phase, and they will receive an open trial of
atomoxetine if they were on placebo during the double-blind phase. All subjects (responders
and nonresponders) will be invited to participate in follow-up assessments every 4 weeks for
24 weeks after the completion of the double-blind phase.
Management Training (PMT) in children with Autism, Asperger's Disorder, or Pervasive
Developmental Disorder Not Otherwise Specified (PDDNOS) who have symptoms of Attention
Deficit Hyperactivity Disorder (ADHD). This is a double-blind placebo, parallel study where
the atomoxetine will have a dose titration over a 6 week period. All children will be seen
weekly during this titration period, with additional visits at Week 8 and Week 10. Families
assigned to the PMT arm will have an additional weekly meeting with a clinician for a total
of 9 PMT visits. PMT involves teaching parents to implement behavioral interventions with
their children. Subjects who are clinical responders (ADHD Responders and Compliance
Responders) from the 10 week study period will be followed every 4 weeks in a 24-week
extension study. Subjects who are clinical nonresponders will continue in PMT if they
received PMT during the double-blind phase, and they will receive an open trial of
atomoxetine if they were on placebo during the double-blind phase. All subjects (responders
and nonresponders) will be invited to participate in follow-up assessments every 4 weeks for
24 weeks after the completion of the double-blind phase.
Inclusion Criteria:
- Children 5 yrs to 14 years 11 mos with clinical diagnosis of Autism, Asperger's
Disorder, or PDDNOS based upon the ADI-R and clinical evaluation by DSM-IV criteria,
- Mental age equal to or greater than 24 months,
- ADHD symptoms based upon the CASI and clinical confirmed diagnosis,
- CGIS-S rating of 4 or grater for ADHD symptoms,
- A mean item score of >1.5 on both the Parent and Teacher (non-parent caregiver)
SNAP-IV 18 ADHD symptoms or the 9-symptom hyperactive-impulsive subscale (symptoms
must be cross-situational),
- Reliable care provider available to bring subject to clinic visits and weekly
sessions.
Exclusion Criteria:
- DSM-IV diagnosis of schizophrenia, schizoaffective disorder psychotic disorder
NOS,bipolar disorder, or major depression (if accompanied by a family history of
bipolar disorder) based upon evidence of suicidality, CASI, and clinical
interview/history,
- Prior failed adequate trial of atomoxetine,
- Use of other psychotropic medications that produce CNS effects,
- Diagnosis of bipolar disorder, major depression, hypertension, cardiovascular
disease, narrow angle glaucoma, other significant physical illness,
- Pregnancy or sexually active females (intercourse in the past 6 months, reported by
either the subject or caregiver),
- Currently on effective medication treatment for ADHD,
- Prior involvement in Parent Management Training or other similar program,
- Currently on albuterol or taking beta blockers,
- Taking supplements or other complementary medical treatments where dose cannot be
held at current level for duration of study
We found this trial at
3
sites
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
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University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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